Catamenial device for blood leakage prevention

ABSTRACT

A catamenial device for blood leakage prevention composed of an inflatable member and an absorbent intravaginal member such as a tampon. The inflatable member houses a resiliently expandable inflation member generally made of open cell foam, and has an opening for airflow communication between the interior of the inflatable member and the outside environment. During insertion into a vaginal canal, the inflation member is inserted in a contracted state. Upon placement to proper vaginal location, the inflation member expands by resiliency drawing air from the ouside environment into the inflatable member via the opening in the inflatable member. Inflation of the inflatable member can be activated manually by the user or via an intravaginal applicator which has the dual function of inserting and delivering the device into the vagina and that of actuating the inflation of the inflatable member.

RELATED CASES

This application is a Continuation in Part of our copending applicationSer. No. 09/861,332 filed on May 17, 2001, now pending, which is aContinuation in Part of patent application Ser. No. 09/372,861 filed onAug. 12, 1999, now pending, which is a Continuation in Part of ourapplication Ser. No. 08/907,529, filed on Aug. 8, 1997, issued as U.S.Pat. No. 5,947,992 on Sep. 7, 1999, which is a Continuation in Part ofpatent application Ser. No. 08/391,342 filed on Feb. 21, 1995, issued asU.S. Pat. No. 5,674,239 on Oct. 7, 1997.

FIELD OF THE INVENTION

This invention relates to obstetrical-gynecological devices, morespecifically to intravaginal devices designed to collect menstrual bloodand to prevent leaking or exit of blood or any other organic fluid fromthe vagina.

BACKGROUND-DESCRIPTION OF THE PRIOR ART

The vagina is a musculomembranous tubular organ extending from theuterine cervix to the exterior of the body. The vaginal canal is about 9or 10 cm long. Its lumen is generally quite small, and the walls thatsurround it are usually in contact with each other. Various are theorganic fluids which pass through the vaginal canal during the femalelifetime, such as blood, vaginal secretion fluids, amniotic fluid, etc.

An important organic fluid passing through the vaginal canal and exitingthrough the vaginal orifice is blood, either as a result ofphysiological conditions such as the menstrual period or as a result ofpathological conditions such as cervical or endometrial carcinoma. Thevarious inconveniences to women resulting from the occurrence ofphysiological bleeding occurring during the menstrual period haveprompted attempts to regulate or control the outflow of menstrualbleeding according to the women personal and social needs. For thepurpose of controlling the outflow of menstrual blood, vaginal tamponswere introduced a few decades ago. Vaginal tampons are common catamenialdevices made of absorbing material and insertable into the vagina by thefemale user. Due to their absorbing material, tampons, once insertedinto the vagina, begin to absorb upon contact the blood they meet, whichoutflows from the cervical canal into the vagina, and function asreservoirs aiming at delaying exit of the blood from the vaginal orificeconceivably until they become saturated with blood and, in so doing,they exert a regulatory effect on the outflow of menstrual bleeding tomeet women's' needs or preferences.

However, regardless of their absorbency capabilities, tampons, forvarious reasons, are known to allow leakage of menstrual blood at ratherunpredictable time or shortly after insertion, falling short ofproviding the regulatory effect which is the very reason for their use.No known tampon is capable of preventing leakage of blood from thevaginal orifice, regardless of shape, size, intravaginal resting site,absorbency capabilities of the material or materials of which they aremade of, etc. Blood may leak from the vaginal orifice because the tamponis too early saturated with blood or because the blood flow isdisproportionately heavy for the absorbency capabilities of the insertedtampon or because the tampon does not provide an adequate sealing withthe vaginal walls or orifice or for all the above reasons variouslycombined.

Despite the use of tampons, therefore, leakage of blood from the vaginalorifice is almost the rule during the days of the vaginal bleeding andits occurrence may result in a great deal of annoyance and inconvenienceto the woman: leakage indeed actually defeats the main purpose for whichtampons are used.

Prior art deals with the problem of leakage of menstrual blood throughthe tampons, some inventions by providing additional blood reservoirs tothe tampons, some others by increasing the tampons absorbingcapabilities by the means of improved absorbing material, and others byusing absorbing pads to apply in correspondence of the vaginal orificeto capture the blood escaped from the tampon. In all such cases, mainobject of the prior art is rather to minimize and possibly delay theoutflow of blood, rather than reliably preventing the leakage of blooduntil it is the appropriate time for the woman, as determined by thewoman rather than by her endometrium, to permit exit of the menstrualblood from the vaginal orifice. No known catamenial device has beendisclosed to provide means of preventing leakage of menstrual blood byentailing the use of an intravaginal balloon.

Another group of catamenial devices introduced for the purpose ofavoiding leakage of menstrual blood are the menstrual cups. Indeedcup-shaped intravaginal devices for collection of menstrual blood arenot new in the art of feminine hygiene. U.S. Pat. Nos. 3,845,766 byZoller, 3,626,942 by Waldron, 2,534,900 by Chalmers and 5,295,984 byAudrey all disclose a cup shaped menstrual collector made of flexiblematerial impervious to fluid inserted into the vaginal canal for thepurpose of collecting menstrual blood and preventing leakage of bloodfrom the vaginal orifice. These devices all suffer from poor ergonomicdesign. They are all bulky, necessarily of large diameter, difficult toinsert and remove. They all have a resilient circular rim thatregardless of the material is made of is necessarily significantlylarger than the diameter of the vaginal orifice they have to passthrough during insertion and during removal. Regardless of theindividual differences among the menstrual blood collector cups, thegeneral design of all these devices makes their insertion into thevaginal canal an uncomfortable and difficult task. Removal of thesedevices is even more difficult and uncomfortable for the user than theinsertion. Furthermore on their removal spillage of blood is a veryfrequent occurrence. Indeed none of the menstrual cups is provided withan effective simple sealable closure apparatus of the cup opening apt toprevent spillage of blood. A lot of expertise has to be learned by theuser before effective insertion and removal of these devices can beachieved and no matter how expert the user can become, the use of theabove mentioned menstrual cups is unavoidably associated with poortolerance during use, discomfort on insertion and removal and in generaldifficult application.

Zadini et al disclose in their patent application Ser. No. 08/391,342 aninflatable device for sealable closure of the vaginal canal as astanding alone device and as a device associated with an intravaginaltampon. In FIG. 5 of the above cited Zadini's patent, an inflatable cupshaped member is described associated with a tampon. While thisinflatable device offers advantages with respect to the priorly citedmenstrual cups, being undeniably capable of being inserted into thevagina and removed from it in an easy and comfortable fashion beingdeflatable, still has the drawback of not being able to collect theblood escaped from tampon absorption and of allowing spillage of bloodon removal as with all priorly cited menstrual cups.

BRIEF SUMMARY OF THE INVENTION

The present invention comprises an intravaginal inflatable cup shapedmember capable of providing reliable vaginal closure to outflow oforganic fluids such as menstrual blood from the vaginal orifice untilthe woman determines to be the appropriate time for allowing exit of themenstrual blood from the vaginal orifice, and also provides reliablevaginal closure to pathological bleeding. Vaginal closure is achieved byan inflatable member, impermeable to fluids, easily self-adaptable tothe variability of size and shape of the vaginal lumen and to thevariability of smoothness of the vaginal walls, said inflatable memberexpanding to exert a gentle pressure on the vaginal mucosa, such apressure being sufficient to prevent passage of blood between theinflatable member itself and the vaginal mucosa. The inflatable cupshaped device is inserted into the vagina and extracted from it throughthe vaginal orifice in a deflated status allowing an easy and discomfortfree insertion and extraction.

The device is provided with an automatic sealable closure of the openingof the cup to prevent spillage of blood on removal.

The device may be used, as a stand-alone intravaginal device, or may beused in combination with blood absorbing means such as tampons.

When used in cases of pathological vaginal bleeding, the inflatableintravaginal cup-shaped member, comprising material substantiallyimpermeable to fluids, expands to exert pressure on the vaginal mucosato prevent passage of blood between the inflatable device and thevaginal mucosa, such prevention of passage of blood resulting in ablockage to intravaginal transit of blood.

OBJECT OF THE INVENTION

It is an object of the present invention to propose a device thatconceivably offers a solution to the problem of untimely leakage ofmenstrual blood. As such, i.e. if employed as a means for prevention ofleakage of menstrual blood, one embodiment of the present inventioncould be used in combination with blood absorbing material, such astampons.

However, it may also be used alone to provide means for prevention ofblood leakage, or, for that same purpose, it may be used in combinationwith other devices or suitable components employed in association withmenstrual bleeding such as menstrual pads.

It is another object of the present invention to offer a device capableof assuring prevention of blood leakage regardless of the anatomicalsize, shape, changing of direction and of lumen contour of the vagina,as a result of remarkable adaptability to anatomical size, shape,contour of the vagina, and adaptability to contingent changes of size,shape, lumen contour of the vagina, to maintain its outer surface inclose contact with the vaginal mucosa and offer a sealing closure toblood in any condition.

It is another object of this invention to propose an inflatable cupshaped device capable of reliably achieving prevention of leakage ofmenstrual blood while being easy to be worn, conceivably adding nodiscomfort to the female user, by gently applying upon the vaginalmucosa a pressure just barely sufficient to prevent passage of bloodbetween the device and the vaginal mucosa, such a pressure beinggenerally proportional to the pressure, notoriously negligible, exertedby menstrual blood.

It is another object of this invention to propose an inflatable devicecapable of reliably achieving prevention of leakage of menstrual blood,while being easy to insert and likewise easy and comfortable to extract.

It is another object of the present invention to provide an intravaginaldevice capable of preventing, when indicated, leakage or outflow, in anyamount, of organic fluids in general, besides blood, from the vaginalorifice.

It is an object of the present invention to provide an inflatableintravaginal device offering means of prevention of significanthemorrhage in cases for instance of pathological bleeding, by reliablypreventing excessive blood loss from the vagina, by limiting the amountof blood extravasation to an amount not exceeding the maximum capacityof reservoir of a tract of the vagina proximal to the site of placementof said inflatable device, as a result of a blockage exerted by suchinflatable intravaginal device on the vaginal transit of blood. A deviceof this kind may prevent the serious medical complications associatedwith massive vaginal-uterine bleeding and at times may well be a lifesaving device.

It is another object of this invention to provide an inflatable cupshaped device capable of functioning as reservoir for the blood exitingfrom the cervical os.

It is an object of the present invention to provide an inflatablemenstrual cup capable of changing size due to its inflatability. Due toits significantly reduced size when deflated the device is easy toinsert and extract from the vaginal orifice without causing anydiscomfort to the female user experienced by the users of the priorlycited menstrual cups.

It is an object of the present invention to provide an inflatablemenstrual cup capable of automatic sealable closure of its opening onextraction so as to not allow escape of blood from the collector cup atthe time of extraction and disposal.

It is another object of the present invention to provide an intravaginalinflatable member for the prevention of leakage of blood from the vaginacanal with an applicator, the plunger of the applicator being capable ofactuating various type of pneumatic sources to inflate the inflatablemember.

DRAWING FIGURES

FIG. 1 is a side view of the device as it appears in operation, i.e.after inflation.

FIG. 2 is a side view of an alternative form of the device shown afterinflation.

FIG. 3 is a side view of an alternative form of the device shown afterinflation.

FIG. 4 is a cross sectional view of the human female pelvis.

FIG. 5 is a side view of an alternative form of the device shown afterinflation.

FIG. 6 is a side view of an alternative form of the device shown afterinflation.

FIG. 7 is a side view of an alternative form of the device shown afterinflation.

FIG. 8 is a side view of an alternative form of the device shown afterinflation.

FIGS. 9 through 14 show a pneumatic pressure delivery deviceincorporated into a vaginal tampon applicator at different stages ofoperation.

FIG. 15 shows the device of FIG. 2 shown in situ, i.e. inserted andresting inside the vaginal canal and accomplishing the function ofimpeding exiting of blood from the vaginal orifice.

FIG. 16 is a side view of an alternative form of the device as itappears in operation, after inflation.

FIG. 17 is a prospective view of a part the device of FIG. 16.

FIG. 18 is a prospective view of another part the device of FIG. 16.

FIG. 19 is a prospective view of another part the device of FIG. 16.

FIG. 20 is a cross section view of the lower chamber of the device ofFIG. 16 showing an inflating apparatus.

FIG. 20A is a cross section view of the lower chamber of the device ofFIG. 16 showing an alternative type of inflating apparatus similar tothe inflating apparatus shown in FIG. 20.

FIG. 21 is a cross section view of the lower chamber of the device ofFIG. 16 showing an alternative type of inflating apparatus.

FIG. 22 is side view of an alternative form of the device shown inoperation after inflation.

FIG. 23 is a side view of the device of FIG. 16 deflated, with bloodcollected and sealed off, ready to be extracted.

FIG. 24 is a side view of an alternative form of the device associatedwith a tampon, shown after inflation.

FIG. 25 is a side view of the device of FIG. 24 shown deflated, withblood collected and sealed off, ready to be removed.

FIG. 26 is a side view of an alternative form of the device as itappears in operation after inflation.

FIG. 27 is a side view of an alternative form of the inflatable memberin combination with an absorbent member as it appears before inflation.

FIG. 28 is a side view of the inflatable member in combination with theabsorbent member of FIG. 27 as it appears after inflation.

FIG. 29 is a cross section view of the inflatable member of FIG. 27alone without tampon as it appears after inflation.

FIG. 30 is a side view of an alternative form of the inflatable memberassociated with an absorbent member as it appears after inflation.

FIG. 31 is a cross section view of an inflatable member associated withan absorbent member housed within an applicator prior to inflation andinsertion into the vaginal canal.

FIG. 31A is a top view of a detail of the device of FIG. 31.

FIG. 32 is a cross section view of a inflatable member housed within anapplicator prior to inflation and insertion into the vaginal canal.

FIG. 33 is a sagittal cross section view of an alternative form of thedevice combined with a tampon as it appears after inflation.

FIG. 34 is a transversal cross section view of the device of FIG. 33.

FIG. 35 is a sagittal cross section view of an alternative form of thecatamenial device combined with a tampon as it appears after inflation.

FIG. 36 is a cross section view of an alternative form of the devicecombined with a tampon as it appears after inflation.

FIG. 37 is a cross section view of a device similar to device of FIG. 36where the tampon string is connected to the body of the tampon as in aregular tampon.

FIG. 38 is a cross sectional view of device of FIG. 37 within anapplicator before ejection.

DETAILED DESCRIPTION OF THE INVENTION

A typical embodiment of the invention is illustrated in FIG. 1. Thedevice generally indicated at 1 is composed of an inflatable orexpandable member or means or balloon 2 and pneumatic pressure deliverysystem or inflating means 4.

Balloon 2 has walls 3, unidirectional valve 6, which can be constructedas a pivoting flap, operating inlet 5 of tubular member or conduit 10 ofinflating means 4. Inflating means 4 is composed of pressure deliverysource or pump 8 with air intake opening 7 provided with unidirectionalpivoting flap valve 9, and tubular member or conduit 10 connecting pump8 to balloon 2 via valve inlet 5 through unidirectional valve 6.

Balloon 2 can be made of material substantially impermeable to fluids.

Inflatable member 2 may be coated with a suitable means which byinterfacing between the balloon and the vaginal walls providesreversible sealing with the vaginal walls as it will be disclosed in thedescription of the operations.

Such interfacing means could include filtering means which selectivelyallows passage of air or suitable gas while preventing passage of bloodor organic fluids.

The inflatable member 2 can be constructed as a self-deflatable memberafter a predetermined time of inflation.

Such a feature can be achieved with micro porous material allowing airto escape from the inflatable member after inflation at a substantiallypredetermined rate of a change in permeability to air of a suitablematerial included in said inflatable member, said change in permeabilityallowing air to escape from the inflatable member at a substantiallypredetermined time following inflation of the inflatable member.

In operation balloon 2 is inserted by the operator or user in vagina ina deflated status. As shown in FIG. 4, balloon 2, once inserted into thevaginal canal or vagina 30 beyond vaginal orifice 32, is inflated by theoperator-user by means of pumping air or other suitable gas or fluidinside balloon 2 via conduit 10 by acting on pump 8. Balloon 2 will beexpanded by the user-operator acting on pump 8 until wall 3 of balloon 2become in contact, in an expanded status, with vaginal walls 33 ofvagina 30.

Balloon 2, when expanded, will not permit exit of any organic fluid suchas blood from vagina 30 by sealing the walls 33 of vagina 30 to walls 3of balloon 2. Indeed expanded balloon 2 obliterates the space betweenballoon walls 3 of balloon 2 and, vaginal walls 33. Balloon 2 is easilyextracted from the vaginal orifice 32 by pulling on conduit 10 oralternatively by pulling on other means such as a string connected toballoon 2. The operator or user, by pulling on conduit 8 or on the justdescribed string, will decrease the transverse diameter of balloon 2,facilitating its exit from vaginal orifice 31.

FIG. 2 shows another version of the device, generally indicated at 11.In this version balloon 2 is connected to blood absorbing means orvaginal tampon 13. The device is operated exactly as device 1. Tampon 13will provide absorbent action for the blood. Blood which escapes tampon13 is impeded to exit from vaginal orifice by expanded balloon 2.

FIG. 3 shows another version of the device, generally indicated at 20.In this version balloon 2 has extension 2′ engaging correspondent recess17′ of blood absorbing means or tampon 13.

In use, after insertion in vagina, balloon 2 is inflated as describedfor devices 1 and 11. Balloon extension 2′ will also inflate as soon astampon 13 will soften due to absorbency of blood providing littleresistance to radial expansion of extension 2′ of balloon 2. In thisdevice, tampon 13, being pressed against wall 33 of vagina 30 by theexpanded extension 2′ of balloon 2, will contribute to the sealing byobliterating any gap between tampon 13 and vaginal walls 33. Balloon 2,as in the two other described devices, will provide sealable closure ofvaginal canal 30.

FIG. 5 shows yet an alternative form of the device, where balloon 40 iscup-shaped harboring tampon 13. In this version blood will be forced toenter distal end 41 of tampon 13 as balloon 40 encircles tampon 13except in correspondence of distal end 41 of tampon 13, sealing side 42of tampon 13.

FIG. 6 shows an embodiment where the inflatable member 43 is concentricto, and sealed to, a segment 44 of any intravaginal menstrual bloodabsorbing means or tampon 13, where said segment 44 is adapted to beimpermeable to fluids. In such an embodiment the inflatable member 43expands to exert a pressure on the vaginal walls 33 of vagina 30 to sealto fluids the space between the inflatable member 43 and the vaginalwalls 33, providing, in combination with the adapted segment 44 of atampon 13, for a blockage to vaginal transit of menstrual blood ororganic fluids.

FIG. 7 shows another embodiment of the device where balloon 47 iscontained in its entirety within tampon 13.

In use, once balloon 47 is inflated, it will press on correspondingoverlying segment 48 of tampon 13 closing the gap between vaginal walls33 and tampon 13 by compressing segment 48 to the extent of preventingany leakage of blood.

FIG. 8 shows another embodiment, where the intravaginal inflatablemember 45, substantially impermeable to fluids, is contained in theinterior of a segment 46 of a tampon 13. The segment 46 is adapted to besubstantially impermeable to fluids. The inflatable member 45 expands toexert a pressure on the vaginal walls 33 via segment 46 of tampon 13 toseal to fluids the space between segment 46 of tampon 13 and vaginalwalls 33, so as to provide, in combination with the adapted segment 46of tampon 13, a blockage to the vaginal transit of menstrual blood.

FIG. 9 shows a pneumatic pressure delivery system or applicator-inflator50 comprising a standard tampon applicator 51 which incorporates asyringe 52. Operator, after inserting tampon applicator 51 into vagina30, press on syringe barrel 53, which telescopically slides withinapplicator barrel 51 to eject tampon 13 with its connected balloon 2into the vaginal canal 30. FIGS. 10 and 11 illustrate the insertion anddelivery of tampon 13 with its connected balloon 2. As shown in FIG. 12the user-operator, after having fully advanced syringe barrel 53 onapplicator barrel 51, will act on syringe plunger 54, inflating balloon2. As shown in FIG. 14, upon full inflation of balloon 2, furtheradvancement of syringe plunger 54 will result in a disengagement ofapplicator-inflator 50 from tampon 13 and its connected balloon 2.

As shown in FIG. 15, tampon 13 with balloon 2, rests firmly in vaginalcanal 30, providing sealable closure of the canal, preventing any bloodleakage.

FIG. 16 shows an alternative form of the cup-shaped inflatable device ofFIG. 5 in use after inflation. As shown in FIGS. 16, 17, 18 and 19, thedevice generally indicated at 60 is a cup-shaped or inverted dome shapedmember composed of inflatable, generally concave, reservoir orinflatable body means 62 for providing a collection site of menstrualblood and inflatable donut shaped member 64 sealingly connected toreservoir 62 at rim 68 and 68′ of reservoir 62 as better seen in FIGS.17 and 18. Both reservoir 62 and donut shaped member 64 are made ofsubstantially gas and fluid impervious material. Cup shaped member 60has, superiorly, circular opening or mouth 65 delimited by donut shapedmember 64, and has, inferiorly, pole 61 through which exits, or to whichis connected, string 70. As best seen in FIGS. 17 and 19 reservoir 62 ismade of two generally concave or cup shaped thin sheets parallelelyarranged, respectively interior wall 74 and exterior wall 74′ ofsubstantially non compliant material imperious to gas and fluids.Reservoir 62 is composed of a series of elongated chambers 63 regularlyspaced and separated one from another by sealed segments 66 obtained forexample by thermally fusing interior wall 74 and exterior wall 74′ atregular intervals. Chambers 63 are in flow communication superiorly viaupper common chamber 71 with the interior of inflatable donut shapedmember 64 and inferiorly they are in flow communication with lowercommon chamber 72. Donut shaped member 64 is made of substantiallyresilient impervious compliant material such as, for instance, rubber.With device deflated at rest prior to inflation or at the time ofextraction, as shown in FIG. 23, donut member 64, retracts centripetallyas a result of its resiliency, sealingly closing circular opening ormouth 65, not allowing escape of the collected blood at time of removalas it will be described below.

Inflatable cup shaped member 60 can be inflated as all the previouslydescribed devices of FIGS. 1 to 15 via an external source of pneumaticmeans i.e. inflating means, such as for instance a syringe or a bladder,connected to the device via a tubular member or conduit, or can beinflated via internal source of pneumatic means, i.e. internally locatedwithin the device, as illustrated in FIGS. 20, 20A and 21. FIG. 20 showsa type of apparatus of pneumatic source means of inflation housed withinthe inflatable member.

Lower chamber 72 houses bladder 67 having wall 111 made of materialsubstantially impermeable to fluid but not to gasses such as air or CO2.Bladder 67 preferably adheres to segment 77 of interior wall 74 and hasinternal breakable membrane or diaphragm 82 made of material lessresistent to pressure than the material of wall 111, separating uppercompartment 81 from lower compartment 87. Compartment 81 and 87 containcomponents chemically reacting to produce pneumatic means of inflationsuch as air, CO2 or any suitable gas. For instance upper compartment 81may contain an acidic fluid solution 90, such as a solution of citricacid or malic acid or any other suitable acidic solution and lowercompartment 87 contains effervescent substrate 89 such as sodiumbicarbonate or any suitable substrate mixable with the acidic solution90 contained within upper compartment 81 of bladder 67 to generatepneumatic means of inflation or gas, such as CO2.

As better shown in FIG. 20, string 70 is anchored via segment 70′ tosegment 77 of interior wall 74 of reservoir 62, slackly traverses lowerchamber 72 to adhere via segment 70″ to internal surface of exteriorwall 74′ of lower chamber 72 and sealingly exits through exterior wall74′ in proximity of pole 61 of reservoir 62.

In use, the female user compresses bladder 67 between her finger. Sinceclosed upper compartment 81 of bladder 67 is filled with fluids, thepressure applied upon it will result into rupture of membrane 82 whichis made of less resistent material than the wall of bladder 67. Ruptureof membrane 82 allows mixing of acidic solution 90 with effervescentsubstrate 89. Upon mixing of acidic solution 90 with substrate 89, CO2or any other suitable gas will be generated. Being wall of bladder 67made of material permeable to gasses, CO2 or the generated gas willenter and diffuse within reservoir 62 and donut shaped member 64 whichwill inflate up to sealingly engage the wall of the vagina. The devicefully inflated will appear as shown in FIG. 16. Blood flowing from thecervical os will be collected within reservoir 62 and no leakage willoccur due to the fact that donut shaped member 64 and reservoir 62sealingly engage the vaginal wall. Once the female user wants to extractcup shaped member 60 from the vagina she will pull on string 70. Thepulling of string 70 will cut through exterior wall 74′ creating a slitthrough which CO2 or other suitable gas can escape. Due to theimpermeability to fluids of wall of bladder 67, the residual acidicsolution and substrate will remain within bladder 67 and will not bespilled into the vagina. Donut shaped member 64, due to its intrinsicresilient properties will centripetally retract closing circular opening65 not allowing any spillage of blood upon extraction.

FIG. 20A shows an alternative form of inflating apparatus for the mixingof acidic solution 90 with substrate 89. This apparatus is in allsimilar to inflating apparatus of FIG. 20, except for an additionalelement, string 105. String 105 is firmly attached along a diameter ofmembrane 82, traverses lower chamber 72 to sealingly exit throughinvaginated portion 107 of exterior wall 74′. In use, in devicessupplied with string 105, the female user ruptures membrane 82 bypulling on string 105, which upon traction will cut through membrane 82creating a slit which leads to mixing of acidic solution 90 withsubstrate 89. Subsequent steps are identical as for the device withinflating apparatus shown in FIG. 20.

FIG. 21 shows yet an alternative type of apparatus of internal pneumaticsource in all similar to the apparatus illustrated in FIG. 20 with thefollowing differences.

Acidic solution 90 and substrate 89 are no longer present. Bladder 67 isreplaced by capsule or container 67′ which is void of membrane 82.Capsule 67′ has wall 113 and a weaker portion 112 of said wall,positioned in correspondence of puncher 86.

Wall 113 of capsule 67′ is made of material impermeable to gasses andcontains compressed pneumatic means or gas 110, such as CO2 or air.Perforating puncher 86 is attached via flexible arm 87 to the wall 113of capsule 67′, as clearly shown if FIG. 21.

In use, the female user prior to inserting the device into the vaginawill press on pole 61 of wall 74 to puncture membrane 112 of capsule 67′and permit passage of gas 110 or other suitable gas from capsule 67′into reservoir 62 and donut shaped member 64 which will inflate up tosealingly engage the wall of the vagina.

Alternatively, as shown for the device of FIG. 5, inflatable cup shapedmember 40 is inflated by an external source of pneumatic means i.e.inflating means such as for instance a syringe or a bladder via tubularmember or conduit 29. Alternatively an external source of pneumaticmeans applicable to all disclosed devices comprises a capsule containingcompressed air or CO2 or any suitable gas or a bladder containingcomponents chemically reacting to produce the pneumatic means such asCO2 or any suitable gas, said gasses delivered to the inflatable membervia a conduit such as conduit 29 of FIG. 5.

FIGS. 24 and 25 show an alternative form of the device of FIGS. 16through 21 and FIG. 23. The device generally indicated at 100 iscomposed of the same cup shaped member 60 and of tampon or absorbentmember 102. Tampon 102 is connected to cup shaped member 60. The deviceis used exactly as device 60 of FIG. 16. Absorbent member 102 willabsorb blood while cup shaped member 60 will collect the blood escapedfrom absorbent member 102. As shown in FIG. 25, at time of extractiondonut shaped member 64 will circularly retract around tampon 102 notallowing escape of blood collected within reservoir 62.

FIG. 22 shows an alternative form of the device of FIGS. 16 through 21and FIG. 23. The device generally indicated at 150 is composed of agenerally donut shaped inflatable member 64′ to which is connectedreservoir or pouch or bag or body means 62′ for the collection ofmenstrual blood. In this device, reservoir or body means 62′ is nolonger inflatable being made of a thin sheet of flexible substantiallyimpermeable material attached, as above disclosed, to donut shapedmember 64. Device 150 is provided with string 152 attached to pole 154of reservoir 62′ for removal of the device.

Donut shaped member 64 can house any of the inflating apparatusesdescribed in FIGS. 20, 20A and 21 with annexed strings or can beinflated by an external pneumatic source as for the device of FIG. 5.Inflation and deflation of donut shaped member 64 is accomplished as forthe devices of FIG. 16 to FIG. 23. An absorbent member can be harboredwithin the device as for the devices of FIG. 5 and FIGS. 24 and 25.

FIG. 26 shows an alternative form of the device of FIGS. 16 through 21and FIG. 23. In this device, generally indicated at 160, cup shapedinflatable member or reservoir or body means 162 is composed ofinflatable substantially impermeable tube 164, made either of resilientmaterial such as rubber or polyurethane or of a not compliant material,arranged in a coils where spires 166 are sealingly connected to eachother or are connected via an impermeable connecting membrane. Spires166 of tube 164, as arranged, form a wall delimiting cavity 168 for thecollection of menstrual blood. Proximal end 165 of tube 164 can housethe pneumatic source means of inflation such as the ones described inFIGS. 16 through 21. Distal end 167 of tube 164 is sealed to avoidescape of gas. Cup shaped member 162 can house absorbent member 102.

As for the previously described devices, device 162 is inflated eitherby the pneumatic source means of inflation housed within the inflatablecoiled tube 164 or by a connected external pneumatic source. The deviceis inserted into the vagina and extracted as the previuosly describeddevices.

FIGS. 27, 28 and 29 show an alternative form of the inflatable membercombined with an absorbent member. As shown in FIG. 27 the devicegenerally indicated at 200 is composed of absorbent member or tampon 202generally of cylindrical shape and inflatable member or menstrual cup204 similar in shape and function to inflatable member 60 of FIGS. 16,17, 18, 19, shown, prior to use, deflated, partially enveloping thelower segment of absorbent member or tampon 202. String 201 is connectedto bottom of device 200. Inflatable member 204 is substantiallyimpermeable to fluids and gasses. As better shown in FIG. 29, which isacross section of inflatable member 204 alone without tampon 202,inflatable member 204 is formed in its lower end with chamber 206.Chamber 206 house any of the pneumatic source means of inflation shownin FIGS. 20, 20A and 21 and above disclosed in page 9 and 10. Inflatablemember or cup 204 is composed of one or more circular chambers 210,joined together by membrane 211, in flow communication with each othervia conduits 212 as better shown in FIG. 29 and with lower chamber 206.As shown in FIG. 28, once inflated, inflatable member 204 assumes theshape of a cup with reservoir 215. Device 200 is designed to preventleaking of blood from the vagina. While absorbent member or tampon 202absorbs blood, inflatable member or cup 204 has the dual function ofcollecting via reservoir 215 the menstrual blood escaped to tamponabsorption and that of sealing the vaginal canal.

FIG. 30 shows an alternative form of the device generally indicated at220 In this version inflatable member 221 also cup shaped encirclestampon 202 as inflatable member 204 of device 200, with the differencethat inner surface or membrane 222 of inflatable member 221 is sealed tothe surface of lower segment of tampon 202 before and after inflationlacking therefore of a reservoir. Chamber 223 houses at the bottom endof inflatable member 221 any of the pneumatic means of inflation orsource means of gas disclosed in page 9 and 10 and illustrated in FIGS.20, 20A and 21.

FIG. 31 shows an inflatable member connected to a tampon, both housedwithin an applicator which has the dual function of carrying, insertingand delivering the device into the vagina and that of actuating theinflation of the inflatable member. The device generally indicated at230 is composed of vaginal applicator 232, tampon 202 and inflatablemember 254. Tubular applicator or tubular member or means for inserting232, generally made of plastic material or cardboard, is composed of twotubes generally of cylindrical shape slideable into each other in atelescopic fashion: plunger or actuating means 234 and elongated hollowtube 236 of larger diameter. Elongated hollow tube 236 houses within itslumen tampon 202 and inflatable member 234. Upper end 240 of elongatedhollow tube 236 is dome shaped, and, as better shown in FIG. 31A, isformed with stellate opening 242. Resilient triangular concave blades orleaflets curved inward 244 delimit opening 242. Bladder or container orpneumatic source means 67 disclosed in page 9 and illustrated in FIG. 20is housed within lower segment or chamber 245 of inflatable member 234.

In use the operator inserts dome shaped end 240 of applicator 232 intothe vaginal canal lower segment through the vaginal orifice. Theoperator then pushes plunger 234 upward in order to insert and delivertampon 202 with inflatable member 254 connected to it into the vaginalcanal. Blades or leaflets 244 oppose the advancement and exit of tampon202 due to their design and structure through stellate opening 242providing sufficient resistance to advancement of tampon 202 to causeplunger head 234′ to rupture membrane 82 of bladder 67, membrane 82being of less resistant material than wall of bladder 67. As shown inFIG. 20 rupture of membrane 82 allows mixing of acidic solution 90 witheffervescent substrate 89 with generation of CO2. CO2 will inflateinflatable member 254 within the vagina.

Inflatable member 254 can house in its lower chamber 245 bladder orcapsule or container or source means of inflation 67′ disclosed in page10 and illustrated in FIG. 21. Plunger head 234′ will activate theinflating of member 254 by causing the puncture of bladder 67 viaperforating puncher 86.

The actuating of source means of gas to inflate inflatable member 254can be alternatively achieved by rupture of the wall of capsule orcontainer or source means of gas 67′ shown in FIG. 21. Capsule 67′ whichhouses compressed gas 110, can be ruptured simply by direct pressureapplied upon its thin weak wall by plunger head 234′, being bladder 67′interposed between plunger head 234′ and the bottom of tampon 202. Asfor device 230 above described blades or leaflets 244 provide sufficientresistance to advancement of tampon 202 to allow such a rupture.

FIG. 32 shows device 230′ composed of inflatable member 250 containedwithin applicator 232′. Device 230′ is in all similar to device 230 ofFIG. 31 with the difference that tampon 202 is no longer present.Inflation of inflatable member 250 is actuated like inflatable member254 of FIG. 31 except that source means of inflation or gas or bladder67 is directly pressed against blades 244′ of dome shaped end 240′ ofapplicator 232′ by plunger head 234″′ of plunger 234″ until rupture ofmembrane 82 of bladder 67 occurs with subsequent liberation of CO2 toinflate inflatable member 250.

FIGS. 33, 34, 35, 36, 37 and 38 show alternative forms of the catamenialdevice for blood leakage prevention. In all these embodiment inflationof the balloon or inflatable member occurs by air or gas drawn from theoutside into the interior of the balloon and not by air or gas directlyoriginating within the balloon as described for devices illustrated inFIGS. 20, 20A, 21. More specifically expansion by inflation of balloonoccurs by suctioning of air or gas from the outside environment into theinterior of the inflatable member or balloon. Suctioning occurs as aresult of negative pressure gradient being created within the expandablemember or balloon which causes movement of air or gas from the outsideinto the interior of the expandable member or balloon via an airflowcommunication between the interior of the balloon and the outsideenvironment.

Device 300, shown in sagittal cross section view in FIG. 33 and intransversal cross section view in FIG. 34, is composed of inflatablemember or balloon 302, substantially impermeable to gas and fluids,enveloping inflation member or air suctioning member or open cell foammember 304 and absorbent member or intravaginal tampon 306. Balloon 302when fully inflated is grossly of cylindrical or conic shape andpartially encircles a portion of absorbent member or tampon 306, leavingthe rest of tampon 306 exposed for blood absorption. Inflation member304 can be also of spongiform structure.

Inflatable member or balloon 302 is formed with opening 310 at its basefor air flow communication with the outside environment. Suctioning ofair into balloon 302, i.e. inflation of balloon 302, occurs byspontaneous distention of open cells foam member 304 housed withinballoon 302, from a forced compressed state to a resting distendedstate. The forced compressed state of open cell foam member 304 can bevariously achieved and maintained either by actual mechanicalcompression of the open cell foam member 304 or by sealing the air flowcommunication opening 310 between the interior of balloon 302 and theoutside environment, once the air or gas is squeezed out or aspiratedfrom the foam. Upon sealing of opening 310, after compression of foammember 304 or aspiration of air from balloon or inflatable member 302, avacuum pressure will be maintained within inflatable member 302,therefore inflatable member 302 will remain in a contracted state, beinginflatable member 302 substantially impermeable to gas beside to fluids.Contraction of inflatable member 302 will facilitate insertion ofcatamenial device 300 in the vaginal canal.

For the purpose of removal from the vaginal canal device 300 is providedwith string 309.

FIG. 35 shows an alternative version of the catamenial device, generallyindicated at 300′, in which balloon 302′ is cup shaped upon expansion,being formed with reservoir 305 for blood collection. As in device 300balloon or inflatable member 302′ houses open cell foam member or airsuctioning member or inflation member 304′ and is formed also withopening or conduit 310. Inflation member 304′ can be made of sponge-likematerial as inflation member 304 of device 300. Lower segment of tampon306 is housed in reservoir 305, and separated from inner wall 307 ofballoon 302′. Device 300′ is used as device 300.

FIG. 36 shows an alternative form of the catamenial device, generallyindicated at 320, in which suctioning of air into balloon 322 occurs byspontaneous distention of inflation member 324 which is a resilientlyexpandable hollow suction bulb member which spontaneously regains itsshape after having been compressed if airflow communication is not beenclosed after compression. Balloon 322 houses suction bulb member 324visible in FIG. 36 through window 324′, created in the drawing forvisualization of bulb member 324. Bulb member 324 is provided withconduit 327 having opening 310′ for flow communication with the outsideenvironment. Alternatively, suction bulb member 324 may be part of thewall of balloon 322 or fused with it.

FIG. 37 shows an alternative form of the catamenial device much similarto device 300′ of FIG. 35. In this device, generally indicated at 340,absorbent member or tampon 306 is in fact a regular tampon with string309′ attached to the body of tampon 306. A slack 309″ of string 309′, ishoused within the body of resiliently expandable member 304′. String309′ is attached to balloon 302′ via non-airtight attachment 311 inproximity of air conduit or opening 310. Slack 309″ facilitateselongation and streaming of balloon or inflatable member 302′, whichhouses foam member 304′, upon extraction of device 340 from the vaginaby the user pulling on string 309′which in turn will pull attachment 311causing the above mentioned elongation of inflatable member 302.

FIG. 38 shows, in cross section, catamenial device 340 of FIG. 37 housedwithin tampon applicator 332. Applicator 332 may have, as shown in FIG.38, an enlarged segment, 334, in correspondence of which expandablemember 304′ may be stored for a long period of time without compromisingits full distensibility required after ejection from applicator 332,although some material appears to maintain satisfactory distensibilityafter being subjected to high degree of compression for long period oftime. Applicator 332 has a distal tubular segment 333 for housing tampon306 prior to use, and a proximal tubular segment 335 within whichapplicator plunger 330 is slideably engaged. Applicator plunger 330 isformed with contact head 331.

In use, after insertion of distal tubular segment 333 of applicator 332into a woman's vagina, plunger 330 is pushed in by the female user toadvance catamenial device 340 into the vagina. If expandable member 304′is stored in an enlarged segment of applicator 332, as shown in FIG. 38,expandable member 304′, upon forward displacement, will be compressedwithin segment 333 of applicator 332, with consequent expulsion of airthrough opening or conduit 310 of inflatable member 302′. Upon exitingof expandable member 304′ from applicator 332 through applicator opening337, expandable member 304′ will distend by resiliency creating anegative pressure gradient between the inside of inflatable member 302′and the outside environment causing air to be drawn into inflatablemember 302′. In applicators without enlarged segment 334, expandablemember 304′ will remain housed in a compressed state within a tubularsegment such as tubular segment 333 of applicator 332, and will expandupon ejection from the applicator from such compressed state maintainedduring storage of the device.

We claim:
 1. A catamenial device for insertion into a vaginal canalhaving a wall, comprising: a vaginal tampon; an inflatable member toseal the vaginal canal upon inflation; and an inflation member housedwithin said inflatable member to inflate said inflatable member, saidinflatable member comprising an airflow communication between aninterior and outside of said inflatable member.
 2. The catamenial deviceof claim 1, wherein said inflation member housed within said inflatablemember to inflate said inflatable member is a resiliently expandablemember to expand said inflatable member to create a negative pressuregradient between air pressure inside said inflatable member and airpressure outside said inflatable member and, consequently, via saidairflow communication, creating an airflow into said inflatable memberto inflate said inflatable member.
 3. The catamenial device of claim 2,wherein said resiliently expandable member is an open cells foam.
 4. Thecatamenial device of claim 2, wherein said resiliently expandable memberis a sponge.
 5. The catamenial device of claim 2, wherein saidresiliently expandable member is a hollow resiliently expandable member.6. The catamenial device of claim 5 further comprising a tubular memberto carry said absorbent member with said inflatable member housing saidinflation member, into the vaginal canal, said tubular member having anenlarged segment apt to house said inflation member in a compressedstate prior to insertion into the vaginal canal.
 7. A catamenial devicefor insertion into a vaginal canal having a wall, comprising: a bloodabsorbing member exposed for blood absorption; an inflatable member toseal the vaginal canal upon inflation, said inflatable member comprisingan airflow communication between the an interior and outside of saidinflatable member; and an inflation member housed within said inflatablemember to inflate said inflatable member, wherein said inflation memberis a resiliently expandable member to expand said inflatable member tocreate a negative pressure gradient between air pressure inside saidinflatable member and air pressure outside said inflatable member and,consequently, via said airflow communication, creating an airflow intosaid inflatable member to inflate said inflatable member.
 8. Thecatamenial device of claim 7, wherein said resiliently expandable memberis an open cells foam.
 9. The catamenial device of claim 7, wherein saidresiliently expandable member is a sponge.
 10. The catamenial device ofclaim 7, wherein said resiliently expandable member a hollow resilientlyexpandable member.